Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to coronary artery bypass graft and at least one saphenous vein graft
排除标准
- •Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
- •Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- •Estimated glomerular filtration rate (eGFR)<15 mL/min
研究组 & 干预措施
Oral Anticoagulation+Antiplatelet
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
干预措施: Rivaroxaban (Drug)
Oral Anticoagulation
Rivaroxaban 20 mg once daily
干预措施: Rivaroxaban (Drug)
Antiplatet
Aspirin 100 mg once daily
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
MACE
时间窗: 5 years
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Graft Patency
时间窗: 5 years
Time from randomization to the first occurence of saphenous graft oclusion
Major Bleeding
时间窗: 5 years
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
次要结局
- MACE, cardiovascular death(5 years)
- All-cause mortality(5 years)
研究者
Luís Paiva
Luis Paiva
Centro Hospitalar e Universitário de Coimbra, E.P.E.